Full Press Release Details
Pharmaceuticals Reports THIRD quarter 2022 financial results and provides business update
Oral Fadraciclib Daily Dosing Well Tolerated in 18 Evaluable Patients Treated in Dose-Escalation of Phase 1/2 Trial in Advanced Solid
Tumors and Lymphoma -
Two Partial Responses in Lymphoma and 11 Stable Diseases in Advanced Solid Tumors -
Expect to Determine Recommended Phase 2 Dose for Oral Fadraciclib
Start Phase 2 in 1Q 2023 -
Encouraging Activity in First Dose Level of Oral CYC140, PLK1 Inhibitor, with Durable Stable Disease in Two Patients with Ovarian and
KRAS G12V mutated Non-Small Cell Lung Cancers -
Cash Runway To End of 2023 -
Conference Call Scheduled for November 9, 2022 at 4:30 pm ET -
NJ, November 9, 2022 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"),
a biopharmaceutical company developing innovative medicines based on cancer cell biology, today announced third quarter 2022 financial
results and provided a business update.
R&D Day highlighted interim clinical data emerging from our ongoing Phase 1/2 study of oral fadraciclib in solid tumors and lymphoma,"
said Spiro Rombotis, President and Chief Executive Officer. "We are excited about fadra's tolerability profile, as well as
clear evidence of its anticancer activity as a single agent in late-line patients with lymphoma, gynecological, liver and pancreatic
cancers. Moreover, we are seeing this activity during dose-escalation which is designed to evaluate safety. We expect to shortly determine
the recommended Phase 2 dose (RP2D) and advance into Phase 2 proof-of-concept stage. We look forward to reporting updated data from our
ongoing Phase 1/2 studies of fadraciclib and CYC140 in 2023."
progress with our two clinical-stage programs, oral fadraciclib (CDK2/9 inhibitor) and oral CYC140 (PLK1 inhibitor), at our recent R&D
Day and the ENA 2022 meeting," said Mark Kirschbaum, M.D., Chief Medical Officer. "In the 065-101 study of oral fadra, we
have reached the sixth dose level after observing that fadra was well tolerated in the first five dose levels. Two out of three lymphoma
patients achieved partial response and 11/15 patients with cervical, endometrial, hepatocellular and ovarian cancers achieved stable
disease with target lesion reductions. A pancreatic patient achieved stable disease for 5 cycles of treatment. In addition, we achieved
levels of fadraciclib that are adequate to inhibit CDK2 and CDK9 for approximately 5 to 7 hours per dose on continuous dosing.
At our R&D Day, we also reported preliminary data from the first two dose levels of our Phase 1/2 study of oral CYC140 in
patients with advanced solid tumors and lymphoma. We were surprised to observe stable disease at the first dose level in an ongoing patient
with metastatic, KRAS G12V mutated, non-small cell lung cancer for 6 cycles and a patient with metastatic ovarian cancer for 5 cycles.
We believe that CYC140 is differentiated from other PLK1 inhibitors by its PLK-centric kinase profile and by inhibiting BRD4, a validated,
epigenetic target in cancer biology."
Corporate Highlights
results from oral fadraciclib 065-101 Phase 1/2 study in advanced solid tumors and lymphoma
| o | 18 evaluable patients with advanced solid tumors or lymphoma were treated in DL 1-5 (median treatment duration of 2.4 cycles; range 1-5 cycles) | |
| o | Well tolerated at all dose levels thus far | |
| o | 2/3 partial responses (PR) in T-cell lymphoma patients; 4 patients with cervical, endometrial, hepatocellular and ovarian cancer) showed stable disease with target lesion reductions and a pancreatic cancer patient achieved stable disease for 5 cycles | |
| o | Achieved target engagement levels predicted to inhibit CDK2 and CDK9 for approximately 5 to 7 hours per dose on continuous dosing | |
| o | Enrollment continues at DL6 (150mg twice a day, Monday-Friday, weeks 1-4) | |
| o | A principal investigator from Seoul National University Hospital presented preclinical data showing sensitivity to fadra in biliary tract and pancreatic cancer cells obtained from patient specimens |
findings from oral CYC140 140-101 Phase 1/2 study in advanced solid tumors and lymphoma
| o | No dose limiting toxicities observed to date in the first two doses levels (DL1-2) | |
| o | Stable disease at dose level 1 in an ongoing patient with metastatic, KRAS G12V mutated, non-small cell lung cancer for 6 cycles and a patient with metastatic ovarian cancer for 5 cycles |
Key Near-Term Business
Objectives and Expected Timeline
of September 30, 2022, cash and cash equivalents totaled $23.7 million, compared to $36.6 million as of December 31, 2021. Net cash used
in operating activities was $15.7 million for the nine months ended September 30, 2022 compared to $14.0 million for the same period
of 2021. The Company estimates that its available cash will fund currently planned programs to the end of 2023.
Research and development
(R&D) expenses were $4.4 million for the three months ended September 30, 2022, as compared to $4.2 million for the same period in
2021. R&D expenses relating to fadraciclib were $2.5 million for the three months ended September 30, 2022, as compared to $3.3 million
for the same period in 2021, due to decrease in clinical trial costs of $0.3 million associated with ongoing clinical trials evaluating
fadraciclib in Phase 1/2 studies and a reduction of $0.5 million in non-clinical expenditures. R&D expenses related to CYC140 were
$1.7 million for the three months ended September 30, 2022, as compared to $0.7 million for the same period in 2021, due to clinical trial
costs associated with the CYC140 Phase 1/2 study.
General and administrative
expenses for the three months ended September 30, 2022 were $2.1 million, compared to $1.8 million for the same period of the previous
year, due to an increase in professional and legal costs.
net, for the three months ended September 30, 2022 was $0.4 million, compared to $13,000 for the same period of the previous year. The
increase of $0.3 million for the three months ended September 30, 2022, is primarily related to foreign exchange gains.
Kingdom research & development tax credits were $1.0 million for each of the three months ended September 30, 2022 and September
30, 2021 and are directly correlated to qualifying research and development expenditure.
loss for the three months ended September 30, 2022 was $5.1 million, compared to $5.0 million for the same period in 2021.
(800) 579-2543 / international call: (785) 424-1789
(888) 276-5315 / international archive: (402) 220-2332
for live and archived conference call is CYCCQ322. Webcast Link
the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com.
The webcast will be archived for 90 days and the audio replay for 7 days.
Pharmaceuticals, Inc.
a clinical-stage, biopharmaceutical company developing innovative cancer medicines based on cell cycle, transcriptional regulation and
mitosis biology. The transcriptional regulation program is evaluating fadraciclib, a CDK2/9 inhibitor, and the anti-mitotic program CYC140,
a PLK1 inhibitor, in patients with both solid tumors and hematological malignancies. Cyclacel's strategy is to build a diversified
biopharmaceutical business based on a pipeline of novel drug candidates addressing oncology and hematology indications. For additional
information, please visit www.cyclacel.com.
news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially
different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking
statements include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel's product
candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials
and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates
that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical
trials, trials may have difficulty enrolling, Cyclacel may not obtain approval to market its product candidates, the risks
associated with reliance on outside financing to meet capital requirements, the potential effects of the COVID-19 pandemic, and the risks
associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates.
You are urged to consider statements that include the words "may," "will," "would," "could,"
"should," "believes," "estimates," "projects," "potential," "expects," "plans,"
"anticipates," "intends," "continues," "forecast," "designed," "goal," or
the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the
risks and uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings
we file with the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements
are current only as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result
of new information, future events or otherwise.
| Company: | Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com |
| Investor Relations: | Irina Koffler, LifeSci Advisors, LLC, (646) 970-4681, ikoffler@lifesciadvisors.com |
SOURCE: Cyclacel Pharmaceuticals,
CYCLACEL PHARMACEUTICALS,
CONSOLIDATED STATEMENTS OF OPERATIONS (LOSS)
share and per share amounts)
| Three Months Ended | ||||||||
| September 30, | ||||||||
| 2022 | 2021 | |||||||
| Revenues: | ||||||||
| Total revenues | - | - | ||||||
| Operating expenses: | ||||||||
| Research and development | 4,413 | 4,217 | ||||||
| General and administrative | 2,054 | 1,781 | ||||||
| Total operating expenses | 6,467 | 5,998 | ||||||
| Operating loss | (6,467 | ) | (5,998 | ) | ||||
| Other income (expense): | ||||||||
| Foreign exchange gains (losses) | 276 | 9 | ||||||
| Interest income | 67 | 4 | ||||||
| Other income, net | 14 | - | ||||||
| Total other income (expense), net | 357 | 13 | ||||||
| Loss before taxes | (6,110 | ) | (5,985 | ) | ||||
| Income tax benefit | 1,014 | 998 | ||||||
| Net loss | (5,096 | ) | (4,987 | ) | ||||
| Dividend on convertible exchangeable preferred shares | (50 | ) | (50 | ) | ||||
| Net loss applicable to common shareholders | $ | (5,146 | ) | $ | (5,037 | ) | ||
| Basic and diluted earnings per common share: | ||||||||
| Net loss per share - basic and diluted | $ | (0.42 | ) | $ | (0.54 | ) | ||
| Weighted average common shares outstanding | 12,314,679 | 9,368,056 |
CYCLACEL PHARMACEUTICALS,
share, per share, and liquidation preference amounts)
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 23,706 | $ | 36,559 | ||||
| Prepaid expenses and other current assets | 4,209 | 4,383 | ||||||
| Total current assets | 27,915 | 40,942 | ||||||
| Property and equipment, net Property and equipment, net | 37 | 64 | ||||||
| Right-of-use lease asset | 153 | 30 | ||||||
| Property and equipment, net Non-current deposits | 2,916 | 1,551 | ||||||
| Total assets | $ | 31,021 | $ | 42,587 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 983 | $ | 2,117 | ||||
| Accrued and other current liabilities | 3,370 | 3,177 | ||||||
| Total current liabilities | 4,353 | 5,294 | ||||||
| Lease liability | 107 | 30 | ||||||
| Total liabilities | 4,460 | 5,324 | ||||||
| Redeemable common stock | 4,494 | - | ||||||
| Stockholders' equity | 22,067 | 37,263 | ||||||
| Total liabilities and stockholders' equity | $ | 31,021 | $ | 42,587 |